Medical device and information container

ABSTRACT

A dynamically configurable medical device and information container is disclosed. The container includes ergonomic features that enable ease of handling and unloading of the contents of the container. Specifically, a configurable section serves as an ergonomic gripping section and a containment section. The container also includes tamper-proof strips that are visible indications of prior opening or tampering with the container. Furthermore, vent holes are implemented to release sterilization gas residues to limit the sterilization gas content of the container.

FIELD OF THE INVENTION

The invention relates to specialized containers adapted to hold and contain a medical device and related information.

BACKGROUND OF THE INVENTION

Containers designed for storing and transporting medical devices and surgical equipment are well known in the art. Generally, these types of containers include a container and a cover with sufficient volume to hold medical devices and components securely. Various types of attachments such as, for example, hinges, snap-on grooves or other structures are used to securely place the cover on the container.

One of the general performance requirements for medical device containers is the need to maintain a protection for a sterilized package from the point of packaging, storage to delivery. Specifically, the primary features of most sterilized medical implant packages are to provide protection of the implants during shipping and enable sterile delivery to the operating room. However, there are several limitations in most of these packages and containers. Primarily, most medical device containers are cumbersome and require various operations to package, deliver and handle. Further, current medical device containers do not appear to provide ergonomic features that are compatible with the handling and delivery of implantable medical devices.

There is, therefore, a need to provide a container for sterile delivery of implantable medical devices, with features and structures that enhance packaging efficiency on the manufacturing floor, promote ease of handling and complement implant procedure efficiency in the operating room.

SUMMARY OF THE INVENTION

The invention is directed to a container for a medical device and related information that is tailored to house, cradle, support and protect the medical device in a sterile environment. Specifically, the container in accordance with the present invention, is dynamically configurable to enable an efficient high volume assembly, packaging, shipping and delivery operation while further enabling safe handling and unpacking of the contents of the container in an orientation suitable for a quick access and removal to implant in a patient.

Among many of the novel features, the invention includes a container with a partial segment that remains closed while allowing access to the medical device when the container is opened. Further, the container includes vent holes to enable a gradual but continuous release of sterilization gas residues such as ethylene oxide or hydrogen peroxide that would otherwise accumulate in the box and may render the package unacceptable in certain jurisdictions with strict emission standards.

In yet another aspect of the invention, the container includes ergonomic features that promote a simple and efficient handling of the container while enabling a secure hand-off to a surgeon in an operating room. The container also provides a tamper-proof indicator that includes a breakaway strip which breaks away when the cover of the container is opened for the first time, thus providing visible proof if the container was ever tampered with or in anyway compromised.

While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description which shows and describes illustrative embodiments of the invention.

As will be realized, the invention is capable of modification in various obvious aspects, all without departing from the scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective drawing of the container in accordance with the present invention.

FIG. 2 is a perspective drawing showing cooperative elements of the present invention.

FIGS. 3A shows a prior art container and FIG. 3B provides the ergonomic aspects of the present invention in comparison thereof.

FIG. 4A depicts the ergonomic and ease of handling aspects of the present invention.

FIG. 4B is a depiction of the ease of handling provided by the present invention.

FIG. 5 illustrates the use of a tray adapted for placement in the container.

FIGS. 6A-6D are cross-sectional views of the container in accordance with the present invention, depicting various elements and details thereof.

FIG. 7A is a side view of the container in a fully open position to accept medical devices in a medical device packaging operation.

FIG. 7B is a plan view showing the internal structures and cooperative elements in accordance with the present invention.

FIGS. 8A and 8B are perspective drawings of an alternate embodiment of the invention.

FIG. 9 is a perspective drawing showing a CD mount.

FIG. 10 is a perspective drawing showing sectional views A-A and B-B.

FIGS. 11A and 1B are sectional views showing support structures for the grip area in accordance with the invention.

FIGS. 12A and 12B are alternate sectional views showing support structures for the grip area in accordance with the invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, container 10 includes bottom shell 12 with flange 14 around the perimeter thereof. Similarly, top shell 16 includes a flange 18 around its perimeter. Bottom shell 12 and top shell 16 are adapted to fit at the flanges to form a containment volume therebetween.

Specifically, bottom shell 12 and top shell 16 are hingeably connected at hinge 22 to enable pivotable separation to thereby maintain container 10 in an open position to accept the medical device. Further, top shell 16 includes living hinge 24 to enable a section of top shell 16 to pivotally open about living hinge 24. Handle grip 26 provides a sure-grip surface for handling container 10. Grip 26 may be selected from various friction surfaces including indentations to fit the fingers, raised strips or regions, shaped depressions, non-skid sinewy surfaces or equivalent.

Referring to FIG. 2, container 10 is dynamically configurable to enable full separation between top shell 16 and bottom shell 12 to load a device in container 10. Specifically, hinge 22 enables a full exposure of the storage and containment region in which the medical device will be stored. After placement of the medical device in container 10, a portion of top shell 16 is secured by means of a plurality of snap-on plugs 32. Plugs 32 provide secure fixation of section 38 by providing a mating between portions of flange 14 and flange 18.

Some elements of the present invention are shown in FIG. 3B for comparison with the prior art container structure of FIG. 3A. Among several innovative aspects, the present invention provides significant ergonomic features in sharp contrast to the prior art. For example, the secure grip area/fixable section 38 of the present invention, enables the hand to grip at the thinnest dimension of the box FIG. 3B as compared to the prior art that would require the hand to span across the bottom of container 10 thus making the handling unstable and cumbersome. Further, this innovative feature enables container 10 to be opened in such a way that the orientation of the implantable device remains in a position suitable for a quick inspection and implant.

Referring to FIG. 4A, container 10 is depicted in its normal closed position with the hand placed in grip area/fixable section 38. FIG. 4B illustrates unlocking latching mechanism/snap-on lock 34 which releases a section of top shell 16 from the closed position to pivot about living hinge 24. This section of top shell 16 is operable while maintaining a grip on the secure grip area 38. This permits the presentation of the device in a sterile condition while providing stability from dislodgement partly because of the support provided in fixable section 38. More specifically, fixable section 38 provides an enclosed pocket in which a portion of the contents of container 10 are sheltered and supported. This arrangement is likely to protect the contents from damage in the event container 10 is dropped or otherwise mishandled while top shell 16 is open.

Further, fixable section 38 provides dynamic configurability to container 10. Specifically, before fixable section 38 is fixed, container 10 is fully open. In this position, contents are placed in container 10. Thereafter, fixable section 38 is anchored yielding a different configuration displaying less than a full volume of container 10.

FIG. 5 depicts an embodiment of a self-supporting tray 36 in which the implantable medical device may be stored. Tray 36 is sterile and may be made from foam or plastic material, including a hollow central interior portion with a flange extending thereabout for placing the medical device and other information therein.

Referring to FIGS. 6A-6D, various details, including vent 28 and the cooperation of living hinge/opening hinge 24, are shown. Specifically, referring to FIG. 6D, at least one breakaway strip 44 is shown in opposition to hinge 24. Breakaway strip 44 operates as a tamper-proof indicator. When latch mechanism 34 is unlocked and opening hinge 24 angulates upward a tensile force is exerted on breakaway strip 44 which ultimately breaks to allow hinge 24 to flex while opening container 10. A broken strip serves as visible proof that container 10 has been opened and/or tampered with thus enabling the end user to reject the package.

FIGS. 7A and 7B depict various features of container 10. Snap-on plug structure 32 permanently locks fixable section 38 in place. FIG. 7A shows, the bottom half of container 12 that could be loaded when hinge 22 is fully open. Thereafter, the device and information is placed in bottom shell 12 and hinge 22 is actuated, snap on plug structure 32 locks together to permanently fix grip area/fixable section 38 as described hereinabove.

Referring to FIG. 7B, an alternate embodiment of vent 28 is shown, including latching mechanism 34 having engageable parts attached both at the bottom shell 12 and top shell 16.

Referring to FIG. 8A, another embodiment of container 10 is shown. Specifically, fix grip area 46 is a cantilevered section with hinge 22 a fixed across the extent of grip area 46.

With reference to FIG. 8B, when latching mechanism 34 is released to biasingly pop up top shell 16, fix grip area 46 remains fixed in relation to top shell 16. Top shell 16 is pivotally connected at hinges 50. This arrangement enables the pivoting movement of top shell 16 while maintaining grip area 46 in a fixed position.

FIG. 9 is a representative of yet another embodiment where CD retainer hub 52 is formed on the inner side of top shell 16. Retainer hub 52 is sized and shaped to receive and retain CD 54.

Referring to FIG. 10 in connection with FIGS. 11A and 11B, a cross-section view of container 10 is shown. Specifically, friction fit 56 is formed from mating extrusions to provide support to grip area 46 and retain it fixed in a cantilevered position.

Similarly, FIGS. 12A and 12B depict another embodiment in which slidable section 58 frictionally engages side wall 14 to provide support to fix grip area 46. Other forms of cantilever connections that support grip area 46 include pegs, posts and other equivalent structures on which grip area 46 may be mounted.

While some selected and representative embodiments have been shown in accordance with the present invention, it should be clear to those skilled in the art that further embodiments may be made without departing from the scope of the present invention. 

1. A dynamically configurable medical device and information container comprising: a first cover with flanges; a second cover with flanges; a hinge pivotably connecting said first cover and said second cover; and a configurable section at said first cover adapted to form a covered containment section and an open containment section between said first cover and said second cover.
 2. The container of claim 1 wherein said configurable section includes a living hinge adapted to enable a portion of said first cover to articulate relative to a remainder portion of said first cover.
 3. The container of claim 2 wherein said remainder portion of said first cover includes retainer means to retain said remainder portion of said first cover in fixed relation to said second cover.
 4. The container of claim 1 wherein said first cover and said second cover are adapted to mate about their perimeters at said flanges and form a storage compartment therebetween.
 5. The container of claim 5 further comprising a snap closure that provides a lock at a free end of the container.
 6. The container of claim 1 wherein said living hinge includes at least one breakaway strip adapted to break when said living hinge articulates thereby indicating prior opening of the container.
 7. The container of claim 3 wherein said remainder portion forms an ergonomic grip section for handling the container.
 8. The container of claim 3 wherein said remainder portion forms a configurable section to vary an open volume of the container.
 9. The container of claim 4 wherein at least one air vent provides an outlet for sterilization gases from said storage compartment.
 10. A dynamically configurable medical device and information container comprising: a lower shell having a plane surface and upwardly extending flanges around the perimeter thereof; an upper shell having a plane surface and downwardly extending flanges around the perimeter thereof; and an operable hinge connecting said lower shell with said upper shell at said upwardly and downwardly extending flanges forming an enclosure therebetween and a living hinge adapted to enable a portion of said upper shell to articulate in relation to a remainder portion of said upper shell.
 11. The container of claim 10 wherein the locking means engageably locks said lower shell with said upper shell to form an enclosure therebetween.
 12. The container of claim 11 wherein said locking means includes a tab member to disengage said lower shell from said upper shell and allow access to the container.
 13. The container of claim 10 wherein a section of said upper shell is engageably locked in place against said lower shell by snap lock means, forming an ergonomic grip section of the container.
 14. The container of claim 13 wherein said snap lock means forms a structure to maintain a portion of said upper shell in fixed relations with said lower shell.
 15. The container of claim 13 wherein said living hinge enables access to said enclosure.
 16. The container of claim 12 wherein said tab disengages said lower shell from said upper shell and said living hinge articulates in relation to a fixed section of said upper shell.
 17. The container of claim 13 wherein said flanges include a vent forming an outlet for gaseous residues contained within said enclosure.
 18. The container of claim 13 wherein said gases include ethylene oxide, chlorine dioxide and hydrogen peroxide.
 19. The container of claim 6 wherein said living hinge includes at least one breakaway strip to indicate tampering.
 20. The container of claim 14 wherein said portion of said upper shell in fixed relations with said lower shell forms a configurable section of the container.
 21. The container of claim 14 wherein said structure forms an ergonomic region for handling the container.
 22. A dynamically configurable medical device and information container, comprising: a lower shell forming a floor and upwardly extending flanges around the perimeter thereof; an upper shell forming a cover and downwardly extending flanges around the perimeter thereof; and an operable hinge connecting said lower shell with said upper shell at said upwardly and downwardly extending flanges forming an enclosure therebetween.
 23. The container of claim 22 wherein a section of said upper shell includes a pivotable portion.
 24. The container of claim 23 wherein a remainder portion of said upper shell remains fixed relative to said pivotable portion.
 25. The container of claim 24 wherein said pivotable portion further includes friction connections to pivotally support said remainder section.
 26. The container of claim 24 wherein said remainder section forms a grip area including a non-skid grip surface. 